PMA P990001S065
- Device
- CLARITY/DA+ C-SERIES/T-SERIES/DIAMOND 3/II/JADE 3/II/RUBY 3/II/SELECTION AFM/TOPAZ 3/II/VITA/2
- Applicant
- Medtronic, Inc.
- PMA number
- P990001
- Supplement
- S065
- Product code
- NVZ
- Decision date
- 2010-04-28
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.
Current openFDA PMA Record
- Device
- CLARITY/DA+ C-SERIES/T-SERIES/DIAMOND 3/II/JADE 3/II/RUBY 3/II/SELECTION AFM/TOPAZ 3/II/VITA/2
- Applicant
- Medtronic, Inc.
- PMA number
- P990001
- Supplement
- S065
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2010-04-28
- Decision code
- OK30
- Date received
- 2010-03-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.